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Safety Report: Lumify copycat eye drops - Warning not to use due to potential eye infection, USA

5 months ago source fda.gov

Outbreak

United States

The Food and Drug Administration (FDA) has issued a warning to consumers against the purchase or use of South Moon, Rebright, and FivFivGo eye drops due to the potential risk of eye infection. These products are unapproved and are easily mistaken for Bausch + Lomb’s Lumify brand eye drops. The FDA has found that these copycat eye drop products claim to treat eye conditions such as glaucoma, which is typically treated with prescription drugs or surgery.

In a recent investigation, the FDA tested samples of South Moon and Rebright eye drops purchased online. The South Moon eye drops were found to be contaminated with Burkholderia cepacia complex, a group of bacteria that could result in an antibiotic-resistant infection. Although Rebright testing was negative for contamination, the FDA still recommends consumers avoid this product. The FDA's testing also revealed that these copycat products lacked brimonidine tartrate, the active ingredient in Lumify. The agency was unable to obtain samples of FivFivGo for testing.

The origin of these products is currently unclear, and the FDA continues to investigate. South Moon is labeled as being produced by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China. The agency advises patients experiencing signs or symptoms of an eye infection to seek immediate medical care.

While the FDA has not received any adverse event reports specifically naming the South Moon, Rebright, or FivFivGo products, it has received reports related to possibly fake Lumify, including product quality concerns, eye irritation, pain, and infection.

The agency recommends consumers only purchase eye products from reputable retailers such as state-licensed pharmacies and be cautious of online retailers selling products with false claims. Check below examples of the images that appear on various websites, warning that some of these copycat products may be falsely labeled with “Bausch + Lomb” at the top of the packaging.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops

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